The victory no one claimed: REPEAL OF DELANEY ENDS AN ERA IN ANIMAL TESTING

From ANIMAL PEOPLE, November 1996:

WASHINGTON D.C. – – Respon-
sible for more animal testing than any other
government standard, the Delaney Clause fell
so softly that when President Bill Clinton on
August 3 signed the Food Quality Protection
Act that repealed it, national press coverage
gave it just one sentence, never mentioning
Delaney by name.
No animal protection group claimed
victory. No environmental or consumer protection
group bewailed defeat. ANIMAL
PEOPLE, aware that repeal of Delaney was
pending, found out it was a fait accompli only
by reviewing the legislative record of the
104th Congress after it adjourned.

Yet repeal of Delaney means that
animal test results are no longer the official
regulatory standard for assessing cancer risk to
human beings. No political action could more
profoundly change animal testing practice and
policy. Though animal test data will still be
collected and used, as regulators deem useful,
it need no longer be collected pro forma;
there is no longer regulatory need to find out
whether a substance may cause cancer in
rodents exposed to abnormally strong doses of
chemicals to which humans may have no discernable
response. The U.S. chemical safety
standard is now just the probability of carcinogenic
effect on human beings, as indicated by
data pertaining directly to human tissues.
Instead of running cancer assays on hundreds
or even thousands of animals, laboratories
may use only a handful of mice genetically
altered to replicate human health effects––or if
cell cultures can be used instead, may do no
testing on animals at all.
The Delaney Clause emerged in
1952 from two years of hearings held by the
House of Representatives Select Committee
on Food Chemicals. Named for committee
chair James J. Delaney, of New York, it stated
“No additive shall be deemed to be safe if it
is found to induce cancer when ingested by
man or animal.”
The latter two words were the mandate
for the greater portion of consumer product
animal testing done over the past 38 years.
Incorporated into the Food Additives
Amendment to the Food, Drug, and
Cosmetic Act of 1958 and the Color Additives
Amendment of 1960, the Delaney Clause
became the primary defense of the American
public against chemical carcinogens.
Delaney was why the FDA banned
root beer flavored with safrole from natural
sassafras leaves in 1960, banned soft drinks
using cyclamate sweeteners in 1966, and
banned all use of saccharin sweeteners in
1977. Each time the public was incredulous
about the application to human health of
rodent testing data showing that the animals
might develop tumors from ingesting the
equivalent of “800 soft drinks a day,” as acting FDA commissioner
Sherwin Gardner put it in 1977. Yet Delaney withstood
all criticism.
Placing the onus of proving that chemicals do not
cause cancer on industry, Delaney was emulated abroad,
especially by nations that export food, drugs, and personal
care products to the U.S., and sparked explosive growth of
animal testing and related activity. Globally, toxicological
testing is now a $4.5 billion-a-year industry, about 80% of it
using animal test subjects.
But despite the cost in both cash and animal suffering,
Delaney never did work well. When Delaney was adopted,
only 424 chemicals of about 700 commonly used in food
production had ever been safety-tested. By 1993, Physicians
Committee for Responsible Medicine researcher Alix Fano
wrote to The New York Times, of “some 70,000 chemicals on
the market, almost half in common use, only 800 have
undergone standard rodent tests used to try to predict human
cancer risk,” as opposed to the LD-50 test, in which
researchers simply feed a group of 100 animals a particular
substance until half of them die. The chemical industry had
simply outgrown the testing methods.
“The cost of running a typical pre-chronic and longterm
rodent carcinogenicity bioassay is $1.6 million to $2.5
million per chemical,” Fano continued. “With more than
25,000 commonly used chemicals awaiting evaluation, to test
them all would cost $50 billion to $75 billion.”
A clandestine industry grew up around finding ways
to comply with Delaney, at least on paper, despite the unpredictability
of LD-50 results. Some laboratories developed
rodent strains with specific resistance to particular types of
chemical. Others laboratories simply faked their test data,
setting up a series of national scandals exposed by media in
the early 1980s. Asbestos, already a suspected carcinogen if
inhaled by humans when Delaney was passed, was for years
paradoxically n o t banned from food and drink, simply
because laboratory animals didn’t live long enough to develop
the long-incubating kinds of cancer associated with it.
Pressured by both consumers and industry, the
FDA and other regulatory bodies circumvented Delaney,
when they could, to keep essential and/or simply popular
chemicals on the market––e.g. saccharin, which would have
been banned in 1972 had Delaney been rigidly enforced, but
was instead kept in a special “interim regulation” category
during five years of retesting.
Silent movement
Except for the Fano critique, animal protection
advocates and antivivisectionists rarely mentioned Delaney by
name, even at the height of anti-animal testing protest in the
early 1980s. Delaney isn’t referenced, for instance, in the
influential critiques of animal testing issued by Barbara
Orlans, Tom Regan, Hans Reusch, Andrew Rowan,
Bernard Rollin, and Peter Singer, nor in any of the major
bibliographies of the animal rights movement, nor even in
America The Poisoned, a 1982 subject category best seller by
then-Fund for Animals board member and staffer Lewis
Regenstein about the use and abuse of pesticides.
As then-Environmental Action editor Rose Adkins
hinted in a 1990 exploration of tensions between animal rights
groups and environmentalists, animal advocates might attack
the methods used to implement Delaney, but never Delaney
itself, the basis of most efforts to ban or restrict
pesticides––itself an animal protection goal since the late
Rachel Carson documented the impact of pesticides on birds
in her 1961 best seller Silent Spring.
The major criticism of Delaney came instead from
University of California at Berkeley biochemist and molecular
biologist Bruce Ames, author of more than 300 scientific
papers, and a former National Cancer Institute board member,
who became a vegetarian nonsmoker when his own
research convinced him nearly 30 years ago that meat-eating
and tobacco smoke are the major causes of human cancer,
and that trace exposure to pesticide residues are of no consequence.
Joined eventually by Lois Swirsky Gold, director of
the Carcinogenic Potency Project at the Lawrence Berkeley
Laboratory since 1980, Ames attacked Delaney from the late
1960s on.
“Zero exposure to rodent carcinogens cannot be
achieved,” Ames and Gold explained often. “Low levels of
rodent carcinogens are ubiquitous in the environment.”
The one crack in Delaney during the first 30 years it
was enforced came when Congress at behest of dieters and
diet product manufacturers exempted saccharin from coverage.
The beginning of the end came when the Environmental
Protection Agency in 1992 accepted the 1987 verdict of the
National Academy of Sciences that Delaney had become
obsolete due to improvements in testing methods and lifted
restrictions on the EBDC class of pesticides, imposed chiefly
because advances in chemical residue detection had enabled
investigators to find carcinogenic materials that couldn’t have
been found a few years earlier.
The Natural Resources Defense Council won a
Pyrrhic victory for Delaney with a July 1992 Federal
Appellate Court verdict that obliged the EPA to enforce
Delaney to the letter, suspending registration of the pesticides
most commonly used on 33 food crops. Taking office six
months later with strong support from agribusiness, the
Clinton administration quietly made amendment of Delaney a
priority. The effort gained momentum from a June 1996
report by the Commission on Risk Assessment and Risk
Management, established by Congress under the Clean Air
Act Amendments of 1990, which argued that finding a chemical
causes cancer in rodents is irrelevant when the mechanism
enabling the cancer to develop isn’t found in humans.
On July 24 the Food Quality Protection Act cleared
the House by a vote of 417-0, the only environmental bill to
draw unanimous support during the 104th Congress.
Whether the end of Delaney will mean marked
reductions in animal testing beyond those already achieved
remains to be seen. The LD-50 test has already been all but
phased out, while cell culture testing has largely replaced the
two-year cancer assays to which Fano referred.